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Development and validation of chromatographic methods for simultaneous determination of ibuprofen and famotidine in presence of related substances in pharmaceutical formulations.
Acta Chim Slov. 2015; 62(1):45-51.AC

Abstract

Two validated methods for the simultaneous determination of ibuprofen and famotidine in the presence of ibuprofen impurity (4-isobutylacetophenone) and or famotidine degradation products were described. The first method was a simple TLC method where separation was performed on silica gel platesusing ethyl acetate: methanol: ammonia (9:2:1, by volume) as a mobile phase. Rf values were found to be 0.40, 0.94, 0.66, 0.27, 0.83 for ibuprofen, 4-isobutylacetophenone, famotidine, famotidine acid and basic degradation products, respectively. The second method is by HPLC on C18 column using methanol: phosphate buffer pH 3 (80:20, v/v) as a mobile phase. Retention times were found to be 2.2, 9.9, and 8.6 for famotidine, ibuprofen, and 4-isobutylacetophenone, respectively. Both methods were validated according to the ICH guidelines and applied for the determination of the two drugs in pure powder and combined dosage form without interference from the excipients.

Authors

Elzanfaly ES
No affiliation info available
Zaazaa HE
No affiliation info available
Soudi AT
No affiliation info available
Salem MY
No affiliation info available

MeSH

Chemistry, PharmaceuticalChromatography, High Pressure LiquidChromatography, Thin LayerFamotidineIbuprofenMolecular Structure

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

25830959

Citation

Elzanfaly, Eman S., et al. "Development and Validation of Chromatographic Methods for Simultaneous Determination of Ibuprofen and Famotidine in Presence of Related Substances in Pharmaceutical Formulations." Acta Chimica Slovenica, vol. 62, no. 1, 2015, pp. 45-51.
Elzanfaly ES, Zaazaa HE, Soudi AT, et al. Development and validation of chromatographic methods for simultaneous determination of ibuprofen and famotidine in presence of related substances in pharmaceutical formulations. Acta Chim Slov. 2015;62(1):45-51.
Elzanfaly, E. S., Zaazaa, H. E., Soudi, A. T., & Salem, M. Y. (2015). Development and validation of chromatographic methods for simultaneous determination of ibuprofen and famotidine in presence of related substances in pharmaceutical formulations. Acta Chimica Slovenica, 62(1), 45-51.
Elzanfaly ES, et al. Development and Validation of Chromatographic Methods for Simultaneous Determination of Ibuprofen and Famotidine in Presence of Related Substances in Pharmaceutical Formulations. Acta Chim Slov. 2015;62(1):45-51. PubMed PMID: 25830959.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of chromatographic methods for simultaneous determination of ibuprofen and famotidine in presence of related substances in pharmaceutical formulations. AU - Elzanfaly,Eman S, AU - Zaazaa,Hala E, AU - Soudi,Aya T, AU - Salem,Maissa Y, PY - 2015/4/2/entrez PY - 2015/4/2/pubmed PY - 2015/5/23/medline SP - 45 EP - 51 JF - Acta chimica Slovenica JO - Acta Chim Slov VL - 62 IS - 1 N2 - Two validated methods for the simultaneous determination of ibuprofen and famotidine in the presence of ibuprofen impurity (4-isobutylacetophenone) and or famotidine degradation products were described. The first method was a simple TLC method where separation was performed on silica gel platesusing ethyl acetate: methanol: ammonia (9:2:1, by volume) as a mobile phase. Rf values were found to be 0.40, 0.94, 0.66, 0.27, 0.83 for ibuprofen, 4-isobutylacetophenone, famotidine, famotidine acid and basic degradation products, respectively. The second method is by HPLC on C18 column using methanol: phosphate buffer pH 3 (80:20, v/v) as a mobile phase. Retention times were found to be 2.2, 9.9, and 8.6 for famotidine, ibuprofen, and 4-isobutylacetophenone, respectively. Both methods were validated according to the ICH guidelines and applied for the determination of the two drugs in pure powder and combined dosage form without interference from the excipients. SN - 1318-0207 UR - https://www.unboundmedicine.com/medline/citation/25830959/Development_and_validation_of_chromatographic_methods_for_simultaneous_determination_of_ibuprofen_and_famotidine_in_presence_of_related_substances_in_pharmaceutical_formulations_ DB - PRIME DP - Unbound Medicine ER -

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